Cleared Traditional

K093588 - EXPLORER 4D TREATMENT PLANNING SYSTEM

K093588 is an FDA 510(k) clearance for EXPLORER 4D TREATMENT PLANNING SYSTEM, manufactured by American Radiosurgery, Inc.. The device is a Class 2 Radiology device with product code MUJ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K093588 · American Radiosurgery, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2010
Decision
53d
Days
Class 2
Risk

K093588 is an FDA 510(k) clearance for the EXPLORER 4D TREATMENT PLANNING SYSTEM. Classified as System, Planning, Radiation Therapy Treatment (product code MUJ), Class II - Special Controls.

Submitted by American Radiosurgery, Inc. (San Diego, US). The FDA issued a Cleared decision on January 11, 2010 after a review of 53 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K093588

510(k) Number K093588 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 2009
Decision Date January 11, 2010
Days to Decision 53 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 107d · This submission: 53d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

MUJ Device Classification - Class 2, Special Controls

Product Code MUJ System, Planning, Radiation Therapy Treatment
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - MUJ System, Planning, Radiation Therapy Treatment

All 256
Devices cleared under the same product code (MUJ) and FDA review panel - the closest regulatory comparables to K093588.
XKNIFE 5
K100417 · Integra Radionics, Inc. · Apr 2010
RAYSTATION VERSION 1.0
K100552 · Raysearch Laboratories AB · Mar 2010
CORVUS RADIATION THERAPY PLANNING SYSTEM
K100092 · Best Nomos · Feb 2010
SIMUPLAN TREATMENT PLANNING SYSTEM
K093391 · Simuplan S.L. · Dec 2009
DOSE VOLUME HISTOGRAM (DVH) EVALUATOR
K092928 · Diversilabs, LLC · Dec 2009
XIO RTP SYSTEM
K092132 · Computerized Medical Systems, Inc. · Sep 2009
K093588 · EXPLORER 4D TREATMENT PLANNING SYSTEM
Download PDF FDA Summary American Radiosurgery…